PRIMAXIN 500 POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Mevcut itibaren:

MERCK CANADA INC

ATC kodu:

J01DH51

INN (International Adı):

IMIPENEM AND CILASTATIN

Doz:

500MG; 500MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

25 VIALS (100 OR 250 ML)

Reçete türü:

Prescription

Terapötik alanı:

CARBAPENEMS

Ürün özeti:

Active ingredient group (AIG) number: 0218820001; AHFS:

Yetkilendirme durumu:

MARKETED

Yetkilendirme tarihi:

2006-12-13

Ürün özellikleri

_ _
_PRIMAXIN_
_®_
_ (imipenem and cilastatin sodium for injection, USP) _
_Page 1 of 61 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PRIMAXIN®
imipenem and cilastatin for injection, USP
500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial
Sterile powder for solution, I.V. Infusion
ANTIBIOTIC
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
JUL 07,1987
Date of Revision:
DEC 21, 2021
Submission Control Number: 253551
_ _
_PRIMAXIN_
_®_
_ (imipenem and cilastatin sodium for injection, USP) _
_Page 2 of 61 _
RECENT MAJOR LABEL CHANGES
4. DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2021
4. DOSAGE AND ADMINISTRATION
06/2020
7. WARNINGS AND PRECAUTIONS
06/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
[To update, right-click anywhere in the Table of Contents and select
“Update Field”, “Update entire
table”, click OK.]
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1 Pediatrics
.......................................................................................................................
6
1.2 Geriatrics
.......................................................................................................................
6
2
CONTRAINDICATIONS
.................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 7
4
DOSAGE AND ADMINISTRATION
................